Systems, methods, and adjunctive procedures for correcting malocclusion

ABSTRACT

Methods of inducing tooth movement and treating malocclusion, craniofacial anomalies, bony defects, and dentofacial deformities through accelerated bone remodeling as caused by the delivery non-static forces; reducing pain and discomfort in patients; and improving tissue integrity long-term results as to prevent post-orthodontic treatment relapse. The methods and apparatus include a mechanism for data capture and analysis related to patient compliance and usage behavior, as well as for establishing the invention as a component of the clinical office workflow to increase efficiency and productivity.

This application claims priority from U.S. Provisional Application Ser.No. 60/906,807, filed on Mar. 14, 2007, the content of which isincorporated by reference.

BACKGROUND

This system relates to systems and methods for treating malocclusion.

Orthodontics is a specialty of dentistry that treats malocclusionthrough the displacement of teeth and control and modification of facialgrowth. This process is accomplished by using mechanical static forcesto induce bone remodeling thereby enabling teeth to move. This widelyaccepted approach to treating malocclusion takes about twenty fourmonths on average. In this approach, orthodontic braces, consisting ofan archwire that applies a continuous static force to the teethinterfaces with brackets that are affixed to each tooth, are used totreat a number of different classifications of clinical malocclusion.These clinical malocclusions include underbites, overbites, cross bites,open bites, and crooked teeth, for both esthetic andfunctional/structural reasons. Recently, removable clear appliances suchas the Invisalign® system have been introduced for treating teeth. Theremovable appliances, as well as the traditional components of theorthodontic system, for example the tooth brackets and an archwire, aredisposable, At an initial visit, during a procedure known as bonding,orthodontic brackets are affixed to the teeth with cement or somesimilar substance with adhesive properties. With the exception ofincidents of damage or loss of brackets, the same brackets aremaintained throughout the entire course of treatment. At the end of thetreatment, the orthodontic brackets are removed. Archwires are typicallychanged at adjustment visits as necessary. The previous archwire isdisposed of each time a new one is ligated to the brackets. These directmaterials are charged to the patient as a cost element of the largertreatment fee, which also includes overhead expenses and direct laborcosts. Fixed appliances, such as retainers that must be worn for someduration post-treatment and clear aligners which are worn until apre-determined subsequent visit, are customized in fit and sold to thepatient. Headgear is typically sold to the patient through theorthodontist and represents a fixed and set cost that must be paidregardless of treatment duration.

Orthodontic treatment can be complicated by the fact that it isoftentimes uncomfortable and painful for patients. Medical devices havenot alleviated the pain associated with this treatment, includinginitial bonding, adjustments, and ongoing discomfort between visits.Post-treatment stability of results and tissue integrity are alsoimportant considerations related to orthodontic treatment. Stability istypically accomplished and enhanced through ongoing wear of retainers,in many cases indefinitely. Compliance issues in wearing retainers canlead to relapses that require additional treatments.

SUMMARY

In one aspect, an orthodontic appliance includes an extraoral vibratorysource and an intraoral dentition interface in the form of a bite plateor platform. A device interface couples the extraoral vibratory sourceto the intraoral attachment.

In another aspect, an orthodontic appliance includes an intraoralvibratory source and an intraoral bite plate or platform that comes intocontact with the dentition. A device interface couples the intraoralvibratory source to the intraoral bite plate or platform.

Implementations of the above aspect can include one or more of thefollowing. A bite plate can be coupled to the extraoral or intraoralvibratory source. The bite plate can interact with any surface of thedentition, especially occlusal.

Furthermore, the interface can contact the teeth at any point and at oneor more points. A processor can control the extraoral or intraoralvibratory source. The processor runs software that captures usagefrequency and duration and can be programmed to change the force,frequency, wave form, amplitude, duration or any other operatingparameter. The processor can communicate usage frequency and duration toa remote computer via any type of wired or wireless communicationmethod. The processor can communicate with the remote computer over theInternet. The processor can actively communicate with the user toprovide input related to device use, especially related to biting toohard or not hard enough on the bite plate or platform. A mechanism canbe provided to measure proper use based on moisture or temperaturesensing, or salivary mineral content sensing, and feedback can beprovided based on this control parameter as well. A non-rechargeable orrechargeable battery can drive the vibratory source, wherein therechargeable battery is charged using power from any type of powersource including a USB port or an RS-232 port or a FireWire port, forexample. The vibratory source can include a motor or a piezoelectricdevice. A leasing, rental or per procedure usage or any other variableusage systems as well as an out right purchase system enables theextraoral vibratory source to be provided to patients a low cost. Thesystem can provide diagnostic information to a service provider. Thesystem also supports recycling the extraoral vibratory source.

In another aspect, a system for treating malocclusion includes a devicethat delivers non-static forces to teeth, the device disposed to teeth,and the device can be leased to a treating professional.

In yet another aspect, a system for treating tooth pain includes adevice that delivers non-static forces to one or more teeth and wherethe device disposed to the teeth provides pain relief.

In yet another aspect, a method for recording the compliant use of anorthodontic device that delivers non-static forces to teeth includes adevice that delivers non-static forces to teeth, where the device havingelectronic media that captures information pertaining to delivery.

In a further aspect, a a system delivers non-static forces to changedental tissue including a jaw, mandible or maxilla. The jaw receivessustained non-static forces that are then delivered to the teethconstituents, and the non-static forces remodels the tissues of themandible, maxilla, or jaw. The device can be used for other type ofmaxillofacial application and trauma like TMJ, Lefort classificationprocedures, tooth and other dental implants, among others.

In other aspects, inducing tooth movement and treating malocclusion,craniofacial anomalies, bony defects, and dentofacial deformitiesthrough accelerated bone remodeling are achieved by the deliverynon-static forces; reducing pain and discomfort in patients; andimproving tissue integrity long-term results as to preventpost-orthodontic treatment relapse. The methods and apparatus include amechanism for data capture and analysis related to patient complianceand usage behavior, as well as for establishing the invention as acomponent of the clinical office workflow to increase efficiency andproductivity.

In another aspect, tooth whitening and stain removal are facilitated byusing the device as a delivery system for some tooth whitening agent,especially dentifrice and bleaching gel or solution. It is understoodthat said agent can exist in any form, including strips, composition,and concentration. The bleaching agent can interact directly with thedental tissue and can also percolate through the orthodontic appliancesso that it is delivered even underneath the brackets.

In yet another aspect, the orthodontic appliance(s) or dentition can becleaned via a brushing mechanism. The benefits of such an adjunctiveapparatus are two-fold: oral hygiene is improved and compliance acrossboth activities, use of the device for orthodontic benefit, as well asfor prophylactic benefit, is enhanced.

Advantages of the system may include one or more of the following. Thesystem enhances the traditional orthodontic treatment process with theapplication of non static forces. In accordance with one embodiment ofthe system, non-static forces are used to accelerate the remodeling ofcraniofacial bones in conjunction with orthodontic treatment. The systemcan be used to treat all forms and classifications of dentalmalocclusion, craniofacial anomaly, boney defect, or dentofacialdeformity in which bone remodeling plays a physiological role. Thesystem can be used exclusively in the maxilla, exclusively in themandible, or in a dual-arch manner (both maxilla and mandible at thesame time). Furthermore, the system can be used to treat casespresenting with a full dentition, any combination of naturally orunnaturally missing teeth, and to remodel bone in edentulous patients.Patients of any age and medical history profile can be treated. Thesystem can be used by patients taking any type of medication.

The system enables orthodontic treatment and tooth movement to beconsidered in the broader context of bone remodeling. The rate-limitingstep for orthodontic tooth movement is osteogenesis. Dynamic loading(cyclic forces) lead to greater osteogenesis or bone growth/boneremodeling, than static forces. Moving teeth is accomplished byremodeling the surrounding alveolar craniofacial bone. Bone remodelinginvolves several steps. First, net bone resorption occurs and takes twoto three weeks. Second, reversal from net resorption to net formationtakes place. Finally, bone formation fills the cavity in three to fourmonths. Osteoclastic activity typically clears the path for toothmovement five to six times faster than osteoblastic activity fills it.Consequently, in order to speed up movement, bone formation(osteogenesis) must speed up.

Certain dynamic loading patterns (higher frequency and inserting restperiods, for example) greatly increase bone formation compared to basicdynamic loading, for example as 1 Hertz sinusoid. Inserting rest periodsis known to be especially efficacious as it allows mechanosensitivity tobe restored to the bone tissue. A point of diminishing returns isreached within each loading session. Therefore, intermittently loadingand uploading with cyclic force can increase the rate of bone formationsignificantly. The system enables an efficacious, yet quick treatmentperiod of static force that involves rapidly changing the forces on theteeth. This is done without requiring the introduction of piezoelectriccurrents to the mechanically stressed bone. Patient compliance isgreatly enhanced through computer monitoring of usage. Treatmentoutcomes are directly dependent on how closely the patient follows theinstructions of the healthcare professional. The system can be worn fora predetermined period such as approximately twenty minutes daily or anyother suitable duration of time, thus the patient can wear the device athome for a modest wear duration. The healthcare professional can measurepatient compliance and usage patterns that have occurred betweenappointments. The measured compliance and application is stored inelectronic means, and is available for retrieval by the health careprofessional; including retrieval over the internet or any othercommunication medium.

The system supports a business model that allows for a non-disposablecomponent of the orthodontic treatment to be variable and proportionalin cost to the duration of the treatment. The device can be disposableor non-disposable. The device can be leased, rented, or purchased on aprocedure basis to the patient directly or through the orthodontist orby a third party. The proposed system also increases orthodontic casethroughput and therefore office efficiency.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one embodiment of an orthodontic treatment system.

FIG. 2 shows a second embodiment of an orthodontic treatment system.

FIG. 3 shows an exemplary diagram of control electronics used with thesystem of FIGS. 1-2.

FIG. 4 shows an exemplary dental treatment network.

FIG. 5 shows an exemplary process for treating patients using thedevices of FIG.

FIG. 6 shows an exemplary process to capture data and provide data forfeedback purposes.

FIG. 7 shows an exemplary system for leasing, renting or purchasing theappliances of FIGS. 1-2.

FIG. 8 shows an exemplary process for improving office and caseefficiency.

FIGS. 9-10 show an exemplary process to compare differences in painlevel for patients treated with and without the appliances of FIGS. 1-2.

FIG. 11 shows an embodiment for the orthodontic treatment system inwhich the device is used as a bleaching or tooth-whitening adjunctivewith the appliance of FIGS. 1-2.

FIG. 12 shows an embodiment for the orthodontic treatment system inwhich the device is used as a tooth-brushing or prophylactic apparatusadjunctive with the appliance of FIGS. 1-2.

DESCRIPTION

Referring now to the drawings in greater detail, there is illustratedtherein structure diagrams for a vibratory dental appliance and logicflow diagrams for the processes a processor will utilize to completetreatment and other dental transactions. It will be understood that theprogram is run on a computer that is capable of communication withconsumers via a network both wired and wirelessly, as will be morereadily understood from a study of the diagrams.

In accordance with one embodiment of the invention, non-static forcesare used to accelerate the remodeling of craniofacial bones inconjunction with orthodontic treatment. The system can be used to treatall forms and classifications of dental malocclusion, craniofacialanomaly, boney defect, or dentofacial deformity in which bone remodelingplays a physiological role. The system can be used exclusively in themaxilla, exclusively in the mandible, or in a dual-arch manner (bothmaxilla and mandible at the same time). Furthermore, the system can beused to treat cases presenting with a full dentition, any combination ofnaturally or unnaturally missing teeth, and to remodel bone inedentulous patients. Patients of any age and medical history profile canbe treated. The system can be used by patients taking any type ofmedication.

FIG. 1 shows one embodiment of an orthodontic treatment system 10. Thesystem or device 10 has an intraoral bite plate 20 that is inserted intoa patient's mouth. The bite plate 10 is connected to an extraoralvibration source 30 and interfaces with the dentition 32. The device 10is clamped down by the patient's jaw 40 on the bite plate 10 to securethe vibration source 30 between the dental arches 42 and to position thesystem in the patient's mouth. The device 10 can interface with any partof the dentition 32, not being confined to a particular arch, region,quadrant, or tooth, and not being confined to either natural dentitionor prosthetic dentition. The vibration source 30 in this embodiment isactivated by pushing a button 38 mounted on the extraoral apparatus. Thevibration source could be activated by sensing the patient bite pressureas stimuli with a microprocessor 39 or some other mechanism translatingthe external stimuli into device function, including moisture ortemperature sensing as well as salivary mineral content sensing.

In another embodiment 10 shown in FIG. 2, the vibration source 30 ispositioned intraorally and holds the components necessary to generateand apply the force. This embodiment can generate and apply non-staticforces to either the maxillary or mandibular arch or both. Thisparticular embodiment involves a dual arch configuration that works withboth dental arches 40. The patient inserts the plate 20 into the oralcavity and bites down, holding the system 10 steady between the teeth,regardless of which of the arches 40 the device is being activated foruse with. The vibration source 30 contained in the intraoral compartment36 is activated by pushing a button 38 mounted to the housing apparatus.The vibration source could be activated by sensing the patient bitepressure as stimuli with a microprocessor 39 or some other mechanismtranslating the external stimuli into device function.

In one embodiment, the device works when the patient applies sufficientforce by biting on the device or otherwise clamping the jaws on thedevice. This enables the device to control the provision of cyclicforces when the correct amount of force is applied. In this embodiment,the device includes 1) microprocessor and compliance software andreporting system; 2) ability to provide cyclic forces at any level; and3) the ability to only provide the cyclic force when the teeth apply thecorrect force on the device. An activation trigger can also be tied tosome other stimuli including temperature or moisture sensing as well assalivary mineral content sensing.

FIG. 3 shows an exemplary diagram of control electronics used with thesystem of FIGS. 1-2. The functional electromechanical components includea processor 50 that can be a low power microcontroller. The processor 50stores instructions and data in a memory 52. The processor drives anactuator 54 such as an electrical motor or a piezoelectric device, amongothers. The system of FIG. 3 receives energy from a battery 62 that canbe rechargeable. The processor 50 can be programmed or updated through acommunication port 60 such as a USB port. Alternatively, the processor50 can be wirelessly updated through a wireless transceiver 58 connectedto an antenna 59. The battery 62 can be of any type and can be arechargeable type with a bite plate docking port that recharges thebattery upon insertion thereto. The processor 50 can also communicatewith an optional sensor 64 to capture patient dental data if needed. Theprocessor 50 can also simply transmits its operational parametersthrough the communication port 60 or the wireless transceiver 58 so thata dental professional such as a dentist, an orthodontist, a hygienist, atreatment coordinator, a staff member, a patient, or a third party canmonitor treatment progress as required.

The actuator 54 can include a motor driven bite plate or platform. Uponactivation, the plate or platform, which can be of any shape orthickness, and comprised of any material, sufficient to come into andout of contact with the dentition 32, in part or in whole, vibrates in amanner that delivers the necessary force. The device can have one ormore interface points across the dentition, or can interface with theentire dentition in aggregate and in both arches simultaneously. Thismovement in total completes one cycle. The system embodied as the devicedescribed here pulsates or vibrates at a frequency of between about 0.1Hertz to about 400 Hertz.

Although a vibrating plate or platform is discussed above, the means ofgenerating the cyclic forces for delivery to the teeth or dentofacialbone structure can be of any form. In one embodiment, the cyclic forcegenerator is mechanically or electrically induced. The generator canalso apply piezoelectric devices as discussed above. Amechano-transduction pathway can be embedded in the system as well.Furthermore, the embodiment of the system can be fixed, removable, orimplantable. The cyclic forces can be also be fluidic in nature.

In one embodiment, the interface with the dentition 32 can transmit aforce of about five Newtons (5N) for about twenty minutes a day at afrequency of between 0.1 to 400 Hz as discussed above. However, theprescribed clinical application of forces can be over any duration,frequency, and time of day combination pattern. Upon completion of one(1) twenty-minute duration of activation, the device automatically shutsoff. Pacing indicators in the form of an audible tone, cycle stutter, orby some other means provide feedback to the patient regarding elapsedtime and time remaining in the current session of activation. Theseindicators can be of any form and frequency; the current describedsystem embodies the indicators as one second tones at five-minuteintervals for the first fifteen minutes, representing a tone at minutefive, minute ten, and minute fifteen; and then a final tone at minutenineteen, indicating that the user has 60 seconds of use remaining.Other indicators and/or suitable treatment intervals can be used toprovide notice to the patient. For example, the professional can specifytreatment intervals that mixes and matches the usage pattern to get tothe 20 minutes such as 4×5 minutes or 10×2 minutes or some othercombinations thereof.

After the device shuts off, the patients simply releases bite pressurefrom the intraoral bite plate and removes the device from the oralcavity. Data capture related to usage frequency and duration updatesreal time. As such, the device representation of this data post-use willindicate one additional session, and twenty additional minutes induration of use, as compared to the same device immediately prior to thesession.

In one embodiment, the battery 62 is rechargeable and can be insertedinto its charger base between uses. Alternatively, the device can embedthe battery 62 within its housing, and the entire device is placed intoa rechargeable base (or the battery does not require re-charging). Thecharging of the battery can be done using power from the USB port 60.Alternatively, any suitable computer or electrical connection can beprovided to charge the battery. For example, the battery can be chargedusing RS-232, Firewire, or through a 5V hook. Further, a standard DCconverter can be used to charge the battery. The device is hermeticallysealed to be airtight and water tight, and can withstand immersion orexposure to water or moisture. It can and should be stored at roomtemperature. The battery 62 used in this particular embodiment is bothmemory-free and maintenance-free. The device can have a charger base, orcan be inserted just long enough to charge for the next use.

The application of cyclic forces can be used to perform bone modelingand/or remodeling as well as more rapid tooth movement that may occurwithout bone modeling or remodeling. The bone remodeling and acceleratedtooth movement across all types of displacement includes: rotation,translation, intrusion, extrusion, and tipping. This induced acceleratedremodeling of bone is relevant for both the alignment and movement ofteeth, in any plane, including horizontal and vertical, anterior andposterior, mesial and distal, and facial (buccal and labial) andlingual.

The delivery of the cyclic forces to the teeth and craniofacial bonescan be facilitated by contact or any form of interaction with thedentition, including any tooth, group of teeth, or arch. The interfacecan also include any dental tissue including tissues of the tooth,enamel, dentin, cementum, and pulp, and appliances, especially alignertrays, which can be of any commercial or non-commercial brand or design.

The system can be used in conjunction with lingual braces, facialbraces, or any combination across either arch or any quadrant for both.It is also being contemplated as compatible with any robotics-based orother wire-bending optimization technology. The system is alsocompatible with clear aligner technology treatment plans, including theInvisalign® treatment approach.

The system can be used in conjunction with a new treatment start fromthe very first appointment at which the orthodontic treatment begins, orit can be slotted into a treatment in progress at any point during thecourse of the treatment, up to and including the very last clinicalstage.

An embodiment of the system can be made available for sale directly toconsumers over-the-counter with no orthodontist or healthcareprofessional involvement. The application being contemplated can be usedto both align and mal-align either a single tooth, the entire dentition,or any combination of teeth groups. Teeth being displaced as a result ofthe non-static forces delivered by this device can include natural teethwithout any dental work, natural teeth with dental work includingoperative restoration of any nature with any material, crown and bridgework, endodontically treated teeth, periodontally treated teeth, teethsurrounded by periodontally treated hard and soft tissue, and any typeof dental implant, including micro implants used for orthodontic ortooth movement purposes. The proposed system can be used in conjunctionwith any type of dental or dentofacial surgery or treatment of trauma toany soft or hard tissue structure.

In another aspect, the system of FIGS. 1-3 can be used in conjunctionwith any currently used or in-development chemical, biochemical, andtissue engineering treatment approaches to accelerating tooth movementor remodeling craniofacial bone. These treatments may include growthfactors, cytokines, matrix metalloproteinases (MMPs), tissue inhibitorsof metalloproteinases (TIMPs), and regulation of extracellular matrixmolecules. In addition, for both repositioning or stabilizing, tissueremodeling and/or an angiogenic substance(s) can be administered to thepatient to promote remodeling of periodontal tissue surrounding theroot(s) of the tooth or teeth to be moved. Preferred substance(s) willbind to and activate the relaxin receptor in the tissues which anchorthe teeth or other craniofacial structures. Most preferred is relaxin oran analog or mimetic thereof which combines tissue remodeling activitywith angiogenic activity. Analogs include peptides, oligomers,fragments, etc. which comprise the active region of native relaxin andmimetics include small molecule drugs, typically below 2 kD, designed tomimic the activity of native relaxin. Alternatively, substance(s) withpredominantly angiogenic activity could be selected, such as VEGF, bFGF,estrogen, nitrous oxide, naltrexone, or the like. Further alternatively,collagenases or other tissue-softening enzymes could be utilized topromote periodontal tissue remodeling according to the presentinvention. In some instances, it may be desirable to combine two or moretissue remodeling and/or angiogenic substance(s) having differingactivities. In other instances it may be desirable to deliver differenttissue remodeling and/or angiogenic substance(s) at different timesduring the orthodontic treatment and/or to different regions of theperiodontal tissue. The term “relaxin” means human relaxin, includingintact full length relaxin or a portion of the relaxin molecule thatretains biological activity, as described in U.S. Pat. No. 5,023,321,preferably recombinant human relaxin (H2), and other active agents withrelaxin-like activity, such as Relaxin and portions that retainbiological activity Like Factor (as described in U.S. Pat. No.5,911,997), relaxin analogs and portions that retain biological activity(as described in U.S. Pat. No. 5,811,395), and agents that competitivelydisplace bound relaxin from a receptor. Relaxin can be made by anymethod known to those skilled in the art, for example, as described inany of U.S. Pat. Nos. 5,759,807; 4,835,251 and co-pending U.S. Ser. No.07/908,766 (PCT US90/02085) and Ser. No. 08/080,354 (PCT US94/0699).More information on applying relaxin to stabilize teeth movement isdescribed in 20040115587 and the foregoing patents, the contents ofwhich are incorporated by reference. It can also be used in conjunctionwith currently existing, in-development, or emerging treatments relatedto innovative mechanotherapy, gene therapy, and growth factor delivery.Relevant sutural genetic considerations to the system include genesexpressed in development, genes responsible forcraniosynostosis/dentofacial deformities, and phenotypes in normal andabnormal development.

FIG. 4 shows an exemplary dental treatment network. The device 10 ofFIG. 1 transmits operational and dental/medical information whileembedded in a patient 1. The data is received by a local processor 99.The local processor 99 in turn uploads the information over a wide areanetwork 100 such as the Internet. The data can be received by a treatingprofessional such as a dentist or an orthodontist at workstation 120.The information can also be sent to one or more diagnostic specialists130 who review the information and then make recommendation to thetreating professional over the network 100. The information can also besent to the device's manufacturer 110 and any other required dentalsupplier 140.

An Internet community with one or more dental supply companies, serviceproviders, manufacturers, or marketers is connected to the network 102and can communicate directly with users of the client workstations 99 orindirectly through the server 100. The Internet community provides theclient workstations 99 with access to a network of orthodonticspecialists and dental specialists. Additionally, the Internet communityalso provides access to a variety of supporting members such asfinancing firms, leasing firms and other service providers, amongothers.

Although the server 100 can be an individual server, the server 100 canalso be a cluster of redundant servers. Such a cluster can provideautomatic data failover, protecting against both hardware and softwarefaults. In this environment, a plurality of servers provides resourcesindependent of each other until one of the servers fails. Each servercan continuously monitor other servers. When one of the servers isunable to respond, the failover process begins. The surviving serveracquires the shared drives and volumes of the failed server and mountsthe volumes contained on the shared drives. Applications that use theshared drives can also be started on the surviving server after thefailover. As soon as the failed server is booted up and thecommunication between servers indicates that the server is ready to ownits shared drives, the servers automatically start the recovery process.Additionally, a server farm can be used. Network requests and serverload conditions can be tracked in real time by the server farmcontroller, and the request can be distributed across the farm ofservers to optimize responsiveness and system capacity. When necessary,the farm can automatically and transparently place additional servercapacity in service as traffic load increases.

The server 100 can also be protected by a firewall. When the firewallreceives a network packet from the network 102, it determines whetherthe transmission is authorized. If so, the firewall examines the headerwithin the packet to determine what encryption algorithm was used toencrypt the packet. Using this algorithm and a secret key, the firewalldecrypts the data and addresses of the source and destination firewallsand sends the data to the server 100. If both the source and destinationare firewalls, the only addresses visible (i.e., unencrypted) on thenetwork are those of the firewall. The addresses of computers on theinternal networks, and, hence, the internal network topology, arehidden. This is called “virtual private networking” (VPN).

The server 100 supports a real estate transaction portal that provides asingle point of integration, access, and navigation through the multipleenterprise systems and information sources facing knowledge usersoperating the client workstations 99. The portal can additionallysupport services that are transaction driven. Once such service isadvertising: each time the user accesses the portal, the clientworkstation 99 downloads information from the server 100. Theinformation can contain commercial messages/links or can containdownloadable software. Based on data collected on users, advertisers mayselectively broadcast messages to users. Messages can be sent throughbanner advertisements, which are images displayed in a window of theportal. A user can click on the image and be routed to an advertiser'sWeb-site. Advertisers pay for the number of advertisements displayed,the number of times users click on advertisements, or based on othercriteria. Alternatively, the portal supports sponsorship programs, whichinvolve providing an advertiser the right to be displayed on the face ofthe port or on a drop down menu for a specified period of time, usuallyone year or less and the sponsorship programs enable campaigning andadditional business models. The portal also supports performance-basedarrangements whose payments are dependent on the success of anadvertising campaign, which may be measured by the number of times usersvisit a Web-site, purchase products or register for services. The portalcan refer users to advertisers' Web-sites when they log on to theportal.

Additionally, the portal offers contents and forums providing focusedarticles, valuable insights, questions and answers, and value-addedinformation about related issues, including information on dentalissues. Other services can be supported as well. For example, a user canrent space on the server to enable him/her to download applicationsoftware (applets) and/or data—anytime and anywhere. By off-loading thestorage on the server, the user minimizes the memory required on theclient workstation 99, thus enabling complex operations to run onminimal computers such as handheld computers and yet still ensures thathe/she can access the application and related information anywhereanytime. Another service is On-line Software Distribution/RentalService. The portal can distribute its software and other softwarecompanies from its server. Additionally, the portal can rent thesoftware so that the user pays only for the actual usage of thesoftware. Such software can include facial modeling software thatrenders the expected teeth position with the facial image of thepatient. After each use, the application is erased and will be reloadedwhen next needed, after paying another transaction usage fee.

The server 100 allows a consumer to log onto a computerized orthodontictransaction system over a network and automates the steps required tocomplete a treatment. In addition, information relating to the variousportions of a transaction are captured and stored in a single convenientlocation where it can be accessed at any time.

The system has several benefits and advantages related to patient anduser compliance. It provides a means by which the healthcareprofessional patient or third-party, like a parent, can observe theusage patterns by the patient related to the device delivering cyclicforces in order to accelerate bone remodeling. The elements ofcompliance that can be tracked include but are not limited to durationof use, frequency of use, confirmation of use by the prescribed patientand not someone else, confirmation of use by the prescribed patient asintended, and any patterns related to misuse or abuse including overuseand underuse. Data analysis as a means of providing rewards orpunishment of any form for proper or improper use is also a part of thecontemplated system. Adjoining any form of pleasurable activityincluding listening to music to the use of the system is anotherbenefit. The proposed device can be compatible with any type of analogor digital music player.

The means of data observation by the healthcare professional can becomputer-based and compatible with any and all operating systems andsoftware/hardware configurations, or via any other form of electronicmedia. Facilitation of data upload could be via USB port or any othermeans of transfer.

The system can be rechargeable or non-rechargeable and can be configuredin a manner that would allow either patient mobility or immobilityduring use. It can be programmed with specific instructions and usagepattern directions by the healthcare professional to ensure safety orfor other reasons, and is configured to give the healthcare professionalthe option of not allowing the patient to have control over theprogrammed settings.

Data captured can be analyzed by the healthcare professional across anyanalytical method, approach, or configuration. Data captured can berepresented graphically, semantically, or in any other format. Data canbe monitored and controlled via the internet.

Another aspect of this system includes a computer implemented system bywhich active or passive feedback can be provided to the patient. Thecapability can exist for any data element related to use or misuse towhich the healthcare professional will have visibility to be madeavailable to the patient in any graphic, semantic, or other form.Furthermore, the capability can exist for the data in the sameaforementioned manner to be made available to the parent or legalguardian of the patient, but not the patient himself. Another feedbackcontemplation of the current system allows the healthcare professionalto real-time track usage by the patient across any data element.

In accordance with the contemplated business aspects of the system, aneconomic model is created which allows the orthodontic or otherhealthcare professional office to rent, lease, or sell the system topatients. It can be used as a means of generating profit within thetreatment office, or can be passed on to the patient under any agreementwithout incremental mark-up for any reason, including as a means ofpromoting the healthcare professional practice. Lease and rentalagreements related to the system can be set up with any term structureand can be configured to allow the orthodontist or other healthcareprofessional discretion as to the pricing and terms of the agreementwith the patient or legal guardian of the patient. The system can beleased or rented to the orthodontist or other healthcare professional bythe commercializing organization so that it is charged pro rata to anytime period increment, especially monthly. The channel strategy used tomarket the current system can be configured so that the point of sale,rent, or lease is established directly between the commercializingorganization and the orthodontic or other healthcare professionaloffice, or it can be established through a leasing company or otherthird party intermediary, and through any number of such intermediaries.

Through any channel of trade, consumer or professional, volume discountscan be configured, and family or sibling discount programs can bedeveloped for multiple users in a single household. Furthermore, thesystem contemplates the development of guarantee and warranty programsrelated to all aspects of the system performance including but notlimited to defects and clinical results.

In yet another aspect, components of the system can be recycled, eitheras a complete unit or at any combination level of components. Thebenefit of such recycling is that the commercializing organization canestablish any number or form of campaigns related to providing rewardsto the orthodontist, other healthcare professional, patient, or legalguardian as recycled parts are procured. In the contemplation of adirect-to-consumer product, all aforementioned campaigns and programscan be established with any channel partner or retailer.

The system improves patient compliance, defined as duration of deviceuse/wear, frequency of device use/wear, consistency in time of daydevice use/wear, and correct device use/wear such data is captured indata form by the device. Compliance refers to both not overusing and notunderusing the device in accordance with the instructions given to thepatient by the healthcare professional. This data can be viewed by thehealthcare professional, as shown in FIG. 5. In this embodiment,instructions for use and wear are provided to the patient by thehealthcare professional (510). The patient uses/wears the device, anddata on compliance is captured during patient use (512). After eachtreatment period, the device is retrieved by the professional andcompliance data is extracted therefrom (514). The data is presented in aform that will allow for data analysis by the healthcare professional(516). As a part of an active feedback process (518), the healthcareprofessional then makes recommendations, or re-prescribes, the devicefor subsequent use until the next visit or interaction. This process caninvolve some form of reward or punishment based on the compliance andusage pattern results.

As shown in FIG. 6, the data can be provided either directly to thepatient or to the legal guardian for feedback purposes as well. Thedevice can be configured as seen in FIG. 6 to provide either active orpassive feedback to the patient user. This data generation andobservation can be enabled by a request via download with some form ofelectronic media, or delivered as a default setting during use. Forexample, during use, the device can provide visual feedback upon request(612) from the patient or automatically (614). The data can bedownloaded (616) into an electronic media 620 such as a flash drive andthe information can be sent to the professional for feedback andanalysis (618), or to the patient directly or to the legal guardian ofthe patient (619).

FIG. 7 demonstrates an exemplary distribution system by company 700where the device 10 is leased or rented to the patient 730 through theorthodontic office 720, allowing for the patient fee to be proportionalto the amount of time that the device is used as a part of thetreatment. Alternatively, the patient could rent or lease the devicedirectly from the commercial sales organization or manufacturer asdemonstrated in FIG. 7. The patient could also purchase the applianceinstead of leasing or renting the device 10, either from the orthodonticor healthcare professional office 720 or from the commercial salesorganization or manufacturer 700.

An additional aspect of the proposed system is related to the efficiencyimprovement that it allows and enables within the orthodontic or otherhealthcare professional office. It can be used to decrease treatmentduration times, increase the number of new starts, improve financialperformance of the practice across any metric, attract new patients,recruit former treatment-rejecters, and improve relations with upstreamor downstream referring or referral dental/medical professionals of anydiscipline or specialty. Healthcare professional efficiency increases asa result of patients using the system. This improvement could includemetrics such as an increased number of new case starts, a shorterduration of total treatment time, frequency of recall or adjustmentvisits, or a decreased amount of chairside time, as shown in FIG. 8. InFIG. 8, the orthodontic office exists in a steady state in office andcase efficiency without the device (810). As the adoption of thetechnology is increased and the devices are incorporated into patientcases, an improvement in the office and case efficiency is achieved(820). These efficiency improvements can occur as a part of or as aresult of any stage of orthodontic treatment of any malocclusionclassification, and with any archwire or appliance type, including allwire sizes, shapes, and compositions.

FIGS. 9-10 show an exemplary process to compare differences in painlevel and integrity of clinical outcomes, respectively, for patientstreated with and without the appliances of FIG. 1 or FIG. 2. FIG. 9demonstrates a decrease in patient pain and discomfort as a result ofusing the device while FIG. 10 demonstrates an improvement in treatmentoutcomes as a result of this device. In FIG. 9, the healthcareprofessional treats the patient without the device of the presentinvention (910) and the level of pain and/or discomfort is observed bythe treating professional or reported by the patient. The healthcareprofessional then treats the patient with the device of the presentinvention and the level of pain and/or discomfort is observed by thetreating professional or reported by the patient is captured (920). Thedifference between the pain level in patients treated with or withoutthe device can be analyzed. The device treats patient with less pain,and the treatment result could be in the form of improved tissueintegrity. The improved result could be observed immediately followingthe treatment or indefinitely into the future beyond the end of thetreatment. The corresponding operations 930 and 940 are shown in FIG.10.

FIG. 11 represents an adjunctive procedure or usage application thatinvolves the delivery of teeth-whitening or bleaching agents to theteeth with the previous appliance contemplated to deliver non-staticforces to the dentition. Some bleaching agent 110 is dispensed eitherdirectly into pre-formed reservoirs 112 or some other form ofagent-holding and delivery function, or into a pump apparatus 114 thatcan be depressed to deliver the agent as desired. It is understood thatthe bleaching agent can be of any composition or concentration and canbe purchased directly by the consumer or prescribed by the dentalprofessional. It is further understood that the design and number ofreservoirs can be of any nature. FIG. 11 demonstrates one embodiment inwhich the reservoirs 112 are located on the insides of the facial flange116 of the device so that they are spatially in contact with the facialsurfaces of the maxillary anterior dentition. The bleaching agent caninteract directly with the dental tissue and can also percolate throughthe orthodontic appliances so that it is delivered even underneath thebrackets.

FIG. 12 represents an embodiment that allows for an adjunctiveapplication related to inducing accelerated tooth movement as well ascleaning the teeth or orthodontic appliances. The cleaning mechanism ismechanical in nature and involves bristles or some similar componentremoving plaque bacteria. Possible forms include an embodiment of thedevice 10 with a tuft(s) of bristles 120 coming into contact with thefacial surface(s) of the dentition 122. The cleaning tufts can includebristles of any form, composition, number, and arrangement. Furthermore,it is understood that a tuft can interact with a single tooth or canspan more than a single tooth. Similarly, tufts 124 can be arranged onthe lingual side of the bite plate apparatus and come into contact withthe lingual surfaces 126 of the teeth. The bristles can interfacedirectly with the teeth or with the orthodontic appliances, especiallythe brackets 128 and the archwire 130. The brushing action can beactivated either automatically upon the sensing of some stimuli such asbite pressure, moisture, or temperature, or can be activated manuallyvia depressing a button 132 that is located in this particularrepresentation extraorally. It is understood that the ratio and locationof bristles or like functional components can be customized to fit aparticular patient.

Expanded indications and applications related to the current systeminclude pain reduction and improved clinical results through improvedtissue and bone integrity. The contemplated reduction of pain applies toinitial adjustments during orthodontic visits, ongoing discomfort levelsbetween orthodontic visits, and post-treatment with any dentofacialsurgery procedure, including trauma and correction of any form. Levelsof discomfort are typically the highest immediately post-adjustmentbecause the tension that is lost due the movement of teeth is recoveredby tightening the archwire. The current system intermittently increasesand then releases this constant pressure at a high frequency. Theresulting perception to the patient is less pain and less discomfort.This observation is partially due to the fact that the device distractsthe patient's attention away from the pain; but it is also a result ofthe subtle release of pressure with the back half of each cycle as thebite plate or platform comes out of contact with the dentition.

The contemplated tissue integrity improvement is related to anycomponent of the periodontium: alveolar bone, periodontal ligament(PDL), cementum tissue, and gingivae. Such a bone integrity and relateddensity improvement also extends to all other dentofacial boneapplications, including bone-healing applications related to thetreatment of trauma. The benefit of such an improvement allows for amore stable result with a higher degree of treatment retention andresulting less treatment relapse as related to the teeth remaining intheir post-treatment position as opposed to migrating back to theirpre-treatment positions. Patients with improved bone density and tissueintegrity do not have to follow the post-treatment retention andretainer regimens that are as rigid. From a functional and structuralperspective, over time the occlusion of the upper and lower arches thengenerates less unnecessary wear to the surfaces of the teeth because thesupporting bone and other tissue structures are stronger and provide asteady foundation. A stronger periodontium also has the benefit of morestable overall oral health.

The above system is advantageous in providing improvement of patientcompliance, development of a leasing business model, improvement ofhealthcare professional office efficiency, and enhancement of treatmentoutcomes through reduced pain and stronger tissue and stability. Thedevice utilizes the application of non static forces. Said forces can becyclic in nature and application. Malocclusion refers to themisalignment of teeth and/or incorrect relation between the teeth of thetwo dental arches. Patient compliance involves behavior as it relates tofollowing treatment instructions and recommendations given by thehealthcare professional. In one embodiment, the proposed system would berented through a leasing business model to patients through healthcareprofessional offices as an intermediary, and serve as a means ofincreasing office throughput and efficiency. The system designed as amedical device in this way decreases patient pain and discomfort andimproves tissue integrity and clinical results.

The invention has been described herein in considerable detail toprovide those skilled in the art with the information needed to applythe novel principles and to construct and use such specializedcomponents as are required. However, it is to be understood that theinvention can be carried out by specifically different equipment anddevices, and that various modifications, both as to the equipmentdetails and operating procedures, can be accomplished without departingfrom the scope of the invention itself. It will be recognized by thoseskilled in the art that changes may be made to the above-describedembodiments of the system without departing from the broad inventiveconcepts thereof. It is understood therefore, that this system is notlimited to the particular embodiment disclosed, but is intended to coverany modifications that are within the scope and spirit of the system asdefined by the appended claims.

1. An orthodontic appliance, comprising: a. an extraoral vibratorysource; b. an intraoral attachment including at least one of: bite plateor platform interfacing with a dentition; and c. an interface couplingthe extraoral vibratory source to the intraoral attachment.
 2. Theorthodontic appliance of claim 1, comprising an intraoral vibratorysource and an interface coupling the intraoral vibratory source to theintraoral attachment.
 3. The orthodontic appliance of claim 1,comprising a processor to control the extraoral vibratory source.
 4. Theorthodontic appliance of claim 2, comprising a processor to control theintraoral vibratory source.
 5. The orthodontic appliance of claim 3,wherein the processor captures usage frequency and duration.
 6. Theorthodontic appliance of claim 3, wherein the processor communicatesusage frequency and duration to a remote computer.
 7. The orthodonticappliance of claim 3, wherein the processor communicates with the remotecomputer over the Internet.
 8. The orthodontic appliance of claim 1,comprising a rechargeable battery to drive the vibratory source.
 9. Theorthodontic appliance of claim 1, wherein the vibratory source comprisesa piezoelectric device.
 10. The orthodontic appliance of claim 1,comprising a bleaching or whitening agent to be applied to teeth. 11.The orthodontic appliance of claim 1, comprising a device to clean orprovide prophylactic benefit to a dentition or an orthodontic appliance.12. A method for treating occlusion, comprising: providing an extraoralvibratory source; placing in a mouth an intraoral attachment includingat least one of: bite plate or platform interfacing with a dentition;and interfacing the extraoral vibratory source to the intraoralattachment.
 13. The method of claim 12, comprising placing in the mouthan intraoral vibratory source and an interface coupling the intraoralvibratory source to the intraoral attachment.
 14. The method of claim12, comprising digitally controlling the extraoral vibratory source witha processor.
 15. The method of claim 12, wherein the processor capturesusage frequency and duration.
 16. The method of claim 12, wherein theprocessor communicates usage frequency and duration to a remotecomputer.
 17. The method of claim 12, comprising leasing the intraoralor extraoral vibratory source.
 18. The method of claim 12, comprisingproviding diagnostic information to a service provider.
 19. The methodof claim 12, comprising recycling the intraoral or extraoral vibratorysource.
 20. The method of claim 12, comprising treating craniofacialanomaly, boney defects, or dentofacial deformity.
 21. The method ofclaim 12, comprising providing stimuli including temperature or moisturesensing as well as salivary mineral content sensing.
 22. The method ofclaim 12, comprising pulsating or vibrating at a frequency of betweenabout 0.1 Hertz to about 400 Hertz.
 23. A method for treating occlusion,comprising: applying a cyclic force to cause dental bone remodeling; andapplying a force to move teeth to predetermined positions.
 24. A methodfor bleaching or whitening the dentition comprising: a. applying anextraoral vibratory source to teeth; b. applying an intraoral attachmentincluding at least one of: bite plate or platform interfacing with adentition; c. coupling the extraoral vibratory source to the intraoralattachment; and d. applying a bleach or whitening agent to the intraoralattachment.
 25. A method for cleaning or providing prophylactic benefitto the dentition or orthodontic appliance(s) comprising: a. applying anextraoral vibratory source to teeth; b. applying an intraoral attachmentincluding at least one of: bite plate or platform interfacing with adentition; c. coupling the extraoral vibratory source to the intraoralattachment; and d. applying a cleaning or prophylactic agent to theintraoral attachment.